A detection method for 5-hydroxymethylfurfural impurity and impurity i in nicardipine hydrochloride glucose injection
A technology of nicardipine hydrochloride and glucose injection, applied in the field of drug analysis, can solve problems such as lack of control and detection, and achieve the effects of promoting the improvement of national standards, easy operation and prolonging life.
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Embodiment 1
[0058] (1) Sample preparation
[0059]Precisely weigh about 20 mg each of 5-hydroxymethylfurfural, nicardipine hydrochloride impurity Ⅰ, and nicardipine hydrochloride into 100 mL volumetric flasks, and dilute to the mark with mobile phase; then precisely measure 5 mL each into 20 mL volumetric flasks, Dilute with mobile phase to form mixed reference substance stock solution (mass concentration is about 50 μg·mL -1 );
[0060] Accurately measure an appropriate amount of the above mixed reference substance stock solution, dilute to the mark with mobile phase, and make mass concentrations of 0.1, 0.5, 1.0, 5.0, 10 and 20 μg·mL -1 As a reference solution;
[0061] Lucifuge operation, take nicardipine hydrochloride glucose injection as need testing solution;
[0062] (2) Standard curve drawing
[0063] Inject the above reference substance solution into the high performance liquid chromatograph, measure the corresponding peak area, take the concentration of the reference substan...
Embodiment 2
[0074] Embodiment 2 methodological investigation
[0075] The specificity, linearity, precision, repeatability, accuracy, stability, detection limit and quantification limit of the detection method of 5-methylfurfural and nicardipine hydrochloride impurity I in nicardipine hydrochloride glucose injection were tested. Methodological investigation. The specific inspection methods are:
[0076] (1) Linear relationship inspection
[0077] Precisely weigh about 20 mg each of 5-hydroxymethylfurfural, nicardipine hydrochloride impurity I and nicardipine hydrochloride into 100 mL measuring bottles, and dilute to the mark with mobile phase. Then each precisely measure 5mL into a 20mL volumetric flask, and dilute it with mobile phase to form a mixed reference substance stock solution (each with a mass concentration of about 50 μg·mL -1 ).
[0078] Accurately measure an appropriate amount of the above mixed reference substance stock solution, dilute to the mark with mobile phase, and...
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